SAS Programmer

JOBDESCRIPTIONOFAnalystSASProgrammer Graduate/Post-GraduateinStatistics/Mathematics/ComputerScience/LifeSciences.

Aminimumof 10 yearsoftotalexperiencewithaatleast 4 yearsofexperienceinStatisticalprogramming and/ordesignandanalysisofPhaseItoPhaseIVclinicaltrialsinaContractResearchOrganizationor PharmaceuticalorBiotechnologycompany Thoroughknowledgeofthepharmaceuticalindustryincludingunderstandingofclinicaldrug developmentprocessandassociateddocumentsandregulations.

GoodknowledgeofGCP,GoodProgrammingPractices,ICH-E3,ICH-E9andotherregulatoryguidance documents(e.

g.USFDAandEMEA) Understandingclientsrequirementandprovidingalltherequiredstatisticalinputson,SAP,Mock Shells,Tables,Listings,Figuresoranyotherstatisticalprogrammingdeliveries Goodunderstandingofthestatisticalprogrammingdomainandrelatedprocesses Assistswithdeveloping,monitoring,andenforcingproductivityandqualitystandardsalongwith relateddocumentations Coordinatingwiththeprojectmanagementinmeetingthetimelineanddefining/capturingthe metricsformonitoringandmaintainingthequalityandproductivity Goodverbalandwrittencommunicationskillscoupledwithgoodorganizationalskills Technical: StrongAnalyticalandprogrammingSkillsusingstatisticalsoftwareSASorequivalentwith understandingofdevelopmentand/orexecutionofSASmacros KnowledgeofRwillbeanaddedadvantage Shouldhaveworkedongeneratingandvalidatingtables,listingsandfigures ShouldhaveworkedonDeriveddatasets/AnalysisDatasets/ADaM/SDTM Morecomplexreview(programswithhighrisk) ProgrammingandreviewofoutputsforDSUR,PSUR,publications ExposureonExploratoryanalysesisanaddedadvantage Programmingandreviewofanalysisdatasets.

Providetrainingandguidancetolowerlevelandnewstaff.

Experienceinsubmissionpackages(Define.xml,SDRG,ADRG,P21reports) Compliance: AdherencetoSOPsandGPP Qualityandadherencetotimelines.

Self-motivationandself-learning Achievementorientation Relationshipbuildingability Inclinationtowardsbeingprocessdriven
B.Pharma
Experienced
Graduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences.

A minimum of 4 years of total experience with a at least 2 years of experience in Statistical programming and/or design and analysis of Phase I to Phase IV clinical trials in a Contract Research Organization or Pharmaceutical or Biotechnology company • Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations.

• Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other regulatory guidance documents (e.g. USFDA and EMEA) • Understanding client’s requirement and providing all the required statistical inputs on, SAP, Mock Shells, Tables, Listings, Figures or any other statistical programming deliveries • Good understanding of the statistical programming domain and related processes • Assists with developing, monitoring, and enforcing productivity and quality standards along with related documentations • Coordinating with the project management in meeting the timeline and defining/ capturing the metrics for monitoring and maintaining the quality and productivity • Good verbal and written communication skills coupled with good organizational skills